For hardware structural components exported to the EU, CE certification is an unavoidable “market pass.” It is important to note that there is no single EU agency that “issues” the CE certification;
the CE mark is the result of a manufacturer’s self-declaration, and the certification process essentially involves completing a statutory conformity assessment procedure.
This article outlines the steps, documentation requirements, and common misconceptions regarding CE certification, based on official EU procedures.
I. Six-Step CE Certification Process
- Step 1: Confirm Applicable Regulations—Identify the relevant EU directives/regulations and harmonized standards for the product (e.g., the Construction Products Regulation [CPR] for construction hardware, the Machinery Directive for machinery components, and the Low Voltage Directive [LVD] and EMC Directive for products with electronic components). If a product falls under multiple directives, it must meet the requirements of all of them.
- Step 2: Determine the Assessment Route—Low-risk products may follow the self-declaration route (Internal Production Control, i.e., Module A). High-risk products or those subject to mandatory directive requirements require the involvement of an EU Notified Body (verifiable via the NANDO database) for type-testing or factory audits.
- Step 3: Conformity Assessment and Testing—Conduct safety, performance, and environmental (e.g., RoHS) testing according to applicable standards. If a product fails testing, corrective actions must be taken followed by re-testing until all requirements are met.
- Step 4: Compile Technical Documentation—Prepare documents such as product specifications, design and manufacturing descriptions, risk assessments, test reports, quality control records, lists of critical components, and user manuals. These documents must be retained for at least 10 years and be available for spot checks by market surveillance authorities.
- Step 5: Sign the EU Declaration of Conformity (DoC)—The manufacturer signs the declaration under their sole responsibility, affirming that the product complies with all applicable EU regulations.
- Step 6: Affix the CE Mark—The mark must be clear, visible, and indelible. If a Notified Body was involved, the body’s identification number must also be displayed.
II.
Required Documentation
When applying to a testing laboratory or Notified Body, the following are typically required: a CE application form, product user manual, technical documentation (including drawings and specifications), and a list of critical components and raw materials; prototype units for testing must be provided if necessary.
Comprehensive technical documentation should also include proof of company registration, product serial numbers or model identification, and details regarding traceability (which may include product photos).
In accordance with EU requirements, manufacturers based outside the EU must also appoint an EU Authorized Representative (EC REP) to handle communications with market surveillance authorities.
III. What Must Be Clearly Stated in the Declaration of Conformity (DoC)
The DoC is a formal, legally binding document that must include: the name and full address of the manufacturer or authorized representative; product serial number, model, or type identification; a statement affirming the manufacturer’s sole responsibility for compliance; means for product traceability; applicable regulations and the harmonized standards relied upon; details of the Notified Body (if applicable);
and the final signature and date. Note: The DoC must be available for inspection alongside the product;
importers and distributors are also obligated to provide it upon request.
IV. Three Common Misconceptions During the Process
- Mistaking CE for a “certificate issued by an agency”: Voluntary certificates must not display the word “certification” or the CE mark—only the CE mark affixed via the manufacturer’s self-declaration serves as a valid market access mark;
- Opting for cheap reports: “CE reports” priced far below market rates likely lack necessary test items or come from agencies not recognized by the EU; goods may be detained upon arrival or face penalties from market surveillance authorities;
- Cutting corners on technical documentation: Technical documentation is a primary focus of market surveillance spot checks; incomplete documentation leaves a product exposed—files must be updated promptly following directive revisions or product modifications.
V.
Trends: Digitalization of Certification and Regulatory Upgrades
The EU is advancing Digital Product Passports and the digitalization of declarations, gradually integrating the Declaration of Conformity with the Digital Product Passport; machinery products will also face stricter requirements under the new Machinery Regulation (EU) 2023/1230 (mandatory from January 20, 2027).
Industry experts recommend incorporating CE compliance into the product development process rather than “retrofitting” it just before shipment: by prioritizing directive identification, testing, documentation, and declaration, hardware manufacturers exporting to the EU can ensure a smooth and compliant process at every stage.
